KR101617015B1 - Record Management Method for Statistical Internal Quality Control of Medical Test Data and Apparatus thereof - Google Patents

Abstract

The present disclosure discloses a quality management method and apparatus thereof, and more particularly, to a history management method and apparatus capable of performing statistical internal quality management of medical examination data conveniently and effectively.
A history management method for statistical internal quality management of medical examination data disclosed in this specification includes a data input step for inputting internal quality control data, a data analysis step for analyzing internal quality control data according to a predetermined evaluation criterion, An interface providing step of outputting the data to the display and providing an interface through which a user can input specific data or action data according to the data analysis result, internal quality management data, data analysis result, And a query output step of outputting at least one of the data storage step and the internal quality management data, the data analysis result, and the measure data to the display according to the request of the user.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a history management method and apparatus for managing statistical internal quality of medical test data,

The present disclosure discloses a quality management method and apparatus thereof, and more particularly, to a history management method and apparatus capable of performing statistical internal quality management of medical examination data conveniently and effectively.

Diagnostics All tests performed in the Department of Medicine are an important part of the medical practice and it is very important to obtain reliable test results. In order to improve the quality of the test, accurate evaluation of the quality of the test is required, and standardization of the inspection work is also an important factor.

Quality control refers to a system of managing test data using scientific and statistical methods so that the test data is always maintained with a certain accuracy and precision so that the medical staff can diagnose and treat with confidence. Quality control is the process of finding medically meaningless analytical errors and analyzing the control material, which means a sample material that is well known to the test results, to compare the current results with the expected results. Normally, the control material is used to confirm whether the (medical) equipment is operating normally and whether the reagent is abnormal.

Since the introduction of the basic principle by Shewart in 1931, since 1977, Westgard introduced the interpretation of the quality control data and the multi-rule on it. The multi rule means a series of rules for judging whether the quality management data is valid or invalid. Six rules are usually used and can be selectively applied according to the number of control levels to be used. The quality control may use statistical methods such as Mean, Standard Deviation, Coefficient of Variation, VIS (Variance Index Score), and SDI (Standard Deviation Index).

Quality management is classified into internal quality management and external quality management.

Internal quality control evaluates the accuracy and accuracy by managing the internal and primary fluctuations of the internal machinery and inspection results. To do so, it documents the quality control materials and methods for each inspection, conducts quality control according to the principles, The results are reviewed and approved by the investigator and the specialist. In addition, inspection and maintenance of inspection equipments, actively reviewing temperature records, and management are also documented, and the approval and implementation are carried out in principle.

A quality control substance is a substance that is composed of one or more constituents that have known concentration and reacts in the same way as a patient sample, and is used to test the accuracy and precision of the test process. In this regard, there is a calibrator material, which means several levels of material that know the concentration, and is used to calibrate the instrument so it can operate normally. Such correction materials should not be used as control materials.

External quality control refers to the quality control performed between laboratories. It is performed by an authorized organization such as a government agency or a society to send a specimen to each laboratory, and the result is analyzed to determine the reliability. The goal is to resolve systematic errors that arise from differences between facilities, equipment, and measurement methods and to maintain accuracy. In Korea, the Korean Society of Clinical Laboratory Standards and the Korean Nuclear Medicine Society are implementing regular schedules.

The Westgard Rule can be used as the analysis standard for the internal quality control, and the analysis standard for the external quality control can be set by setting the self-standard for each hospital referring to the international standard.

In general, external quality control is aimed at improving and maintaining the accuracy of test results, and internal quality control is aimed at improving and maintaining the accuracy of test results. Here, the precision means a scale for judging the reproducibility of two or more measurement values, and the accuracy means a scale for judging the degree of approximation to the expected value.

Conventional quality control activities have to be performed manually by all the management and analysis of the quality control data, and accordingly, it has been difficult to perform quality control according to the principle. Particularly, when various kinds of quality management data have to be collected, it has been more difficult to identify and interpret the uniqueness according to the combination of these data and to determine the action items.
Such degree management is disclosed in Japanese Unexamined Patent Application Publication No. 2007-271641, but it has limitations on the level of statistical processing of only average values and standard deviations excluding extreme values according to the standards applied to the system.

(Patent Document 1) Japanese Unexamined Patent Application Publication No. 2007-271641

In the present specification, a history management method and apparatus for managing the statistical internal quality of medical examination data, which can provide convenience in use in the quality management, and can more effectively identify and interpret unusual matters and determine measures, There is a purpose in providing.

A history management method for statistical internal quality management of medical examination data disclosed in this specification includes a data input step for inputting internal quality control data, a data analysis step for analyzing internal quality control data according to a predetermined evaluation criterion, An interface providing step of outputting the data to the display and providing an interface through which a user can input specific data or action data according to the data analysis result, internal quality management data, data analysis result, And a query output step of outputting at least one of the data storage step and the internal quality management data, the data analysis result, and the measure data to the display according to the request of the user.

According to the inventions disclosed in the present specification, it is possible to provide convenience to the user in the quality management of the medical examination data, to identify and interpret the specific items according to the quality management data, and to determine the measures easily and efficiently There is an effect to be able to do.

1 is a diagram for explaining an embodiment of a history management method for statistical internal quality management of medical examination data disclosed in this specification.
FIG. 2A is an embodiment of a screen on which internal quality control disclosed in this specification is output to a display, and FIG. 2B is an enlarged view on the left half of FIG. 2A.
3A shows a display screen for inputting the correction data disclosed in this specification, and Figs. 3B and 3C are enlarged views of the left and right half of Fig. 3A.
FIG. 4 illustrates a display screen on which a corrective action report output in the report format disclosed herein is output.
5 is a diagram for explaining an embodiment of a history management device for statistical internal quality management of medical examination data disclosed in this specification.

The following merely illustrates the principles of the invention. Therefore, those skilled in the art will be able to devise various apparatuses which, although not explicitly described or shown herein, embody the principles of the invention and are included in the concept and scope of the invention. It is also to be understood that all conditional terms and examples recited in this specification are, in principle, expressly intended for the purpose of enabling the inventive concept to be understood and are not to be construed as limited to such specifically recited embodiments and conditions do.

It is also to be understood that the detailed description, as well as the principles, aspects and embodiments of the invention, as well as specific embodiments thereof, are intended to cover structural and functional equivalents thereof. It is also to be understood that such equivalents include all elements contemplated to perform the same function irrespective of the currently known equivalents as well as the equivalents to be developed in the future, i.e., the structure.

In the claims of the present specification, the elements represented as means for performing the functions described in the detailed description may include, for example, a combination of circuit elements performing the function or any type of software including firmware / And is coupled with appropriate circuitry for executing the software to perform the function. It is to be understood that the invention as defined by the appended claims is not to be interpreted as limiting the scope of the invention as defined by the appended claims, as the functions provided by the various enumerated means are combined and combined with the manner in which the claims require. .

It is to be understood that when an element is referred to as being "connected" or "connected" to another element, it may be directly connected or connected to the other element, . On the other hand, when an element is referred to as being "directly connected" or "directly connected" to another element, it should be understood that there are no other elements in between.

Unless defined otherwise, all terms (including technical and scientific terms) used herein may be used in a sense commonly understood by one of ordinary skill in the art to which this invention belongs. Also, commonly used predefined terms are not ideally or excessively interpreted unless explicitly defined otherwise.

In this specification, a singular form may include plural forms unless specifically stated in the phrase. It is noted that the terms "comprises" and / or "comprising" used in the specification are intended to be inclusive in a manner similar to the components, steps, operations, and / Or additions.

BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which: . In the following description, a detailed description of known technologies related to the present invention will be omitted when it is determined that the gist of the present invention may be unnecessarily blurred. Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The present invention discloses a history management method and apparatus for statistical internal quality management of medical examination data that can provide convenience in use and can more efficiently identify and interpret abnormalities and determine measures. The history management method of statistical internal quality management of medical examination data disclosed in this specification and its apparatus can efficiently manage an enormous amount of medical examination data and can easily check errors of medical examination and take measures Thus, a reliable inspection result can be obtained.

1 is a diagram for explaining an embodiment of a history management method for statistical internal quality management of medical examination data disclosed in this specification.

Referring to FIG. 1, a history management method for managing a statistical internal quality of medical examination data includes a data input step (S101) for receiving internal quality management data, a data analysis step for analyzing internal quality management data according to a predetermined evaluation criterion (S102), an interface providing step (S103) of outputting a data analysis result to a display and providing an interface through which a user can input specific data or action data according to a data analysis result, an internal quality management data, A data storage step (S104) of storing the measure data in a database, and an inquiry outputting step (S105) of outputting at least one of the internal quality control data, the data analysis result and the measure data to the display at the request of the user ).

The internal quality control data may be directly input by the user or transmitted through the network from the data storage means or the inspection equipment. The quality control data may include the overall contents of equipment, reagents, instruments, temperature, etc. for medical examination progress.

The applied internal quality control data is analyzed according to predetermined evaluation criteria. The predetermined evaluation criteria for the internal quality control data here may include the interpretation of the quality control data by Westgard and the rules therefor. The predetermined evaluation criterion can allow the level of the rule to be changed through the interface providing step.

The data analysis result is output to the user through the display, and the user examines the data analysis result together with the quality management data to input the content of the unusual item or a series of measures that the user should take. Such an input interface can implement a user interface so that the user can click on the displayed level management data according to a predetermined evaluation criterion so that the user can be output to the display in the form of a pop-up.

The quality management data, the data analysis result and the measure data are stored in the database and can be output in various classification formats and formats according to the user's request.

The interface providing step (S103) outputs the internal quality management data, distinguishes data within the predetermined evaluation criterion from the output internal quality management data and data exceeding the evaluation criterion, and outputs the internal degree It is possible to provide an interface for inputting the above-mentioned unusual matters or action item data to the management data.

2 is an embodiment of a screen in which internal quality control disclosed in this specification is output to a display.

Referring to FIG. 2, internal quality control data 201 for medical test items AST, ALT, GGT, and the like are inputted. In Fig. 2, the predetermined evaluation criterion is based on 1-3s as W-GR. In the display screen, only the results of the internal quality management data out of the W-GR or the result of the unusual occurrence are displayed in different colors so that the user can easily recognize the data. Particularly, when the cursor is clicked on the corresponding data in the display screen, the pop-up window 202 is displayed in a large size so that the specific data for the corresponding cell or a series of countermeasure data that the user can take do. These inputs can be list-up, select contents, or input texts through the input device. By displaying the uniqueness occurred on the day and the action selected by the user to solve the problem, the internal quality management can be easily performed.

The interface providing step S103 is an interface for outputting the internal quality management data to be output according to one or more medical examination items and outputting the internal quality management data for a predetermined period of time for each medical examination item in the form of a graph . When the ALT test item is clicked in FIG. 2, the data of the test item is output to the display in the form of a graph (203), so that a graph of the medical test item where the unusual occurrence occurs can be immediately confirmed. The information displayed on the graph can be compared with the trends of the quality control material data for the previous 30 days, so that it is easy to check the correlation with the contents of the day and to judge whether or not the medical equipment or reagent condition is abnormal.

Meanwhile, the evaluation criterion W-GR shown in FIG. 2 can be changed and applied to the evaluation criterion (rule) 206 shown in the upper part of FIG.

The interface providing step (S103) may provide an interface for inputting the entire specifics of the plurality of medical examination items or the entire measure data. In FIG. 3, if the user clicks the 'All Item Action' (204) or moves the cursor to the corresponding position, a popup window can be used to input uniqueness or the action taken at once. Calibration according to reagent replacement for each medical test item can be entered through a pop-up window provided by clicking on individual items.

The interface providing step (S103) may provide an interface for displaying an evaluation criterion for data exceeding the evaluation criterion in the graph and a corresponding stored measure on a graph and outputting the graph. Data out of the evaluation criterion can be displayed in the graph 203 output in FIG. 2 and output in the form of a pop-up 202 in the vicinity of the graph 203 or in the column where the corresponding data is written.

The interface providing step (S103) provides an interface for inputting calibration data for the medical examination item, and stores the personal data of the user who inputs the correction data in the correction data.

3 shows a display screen for inputting the correction data disclosed in this specification.

Referring to FIG. 3, if 'Cal History Registration' 301 is selected at the upper right of FIG. 3, history, result, judgment, and action items of correction data for the corresponding date can be inputted. In particular, the personal information of the user (the person in charge of enforcement) who inputs the correction data is automatically generated and stored together with the correction data. This personal information can be implemented by adding a procedure for registering and logging the user in the internal quality control system.

The data registered in accordance with the 'Cal history registering' 301 is selected by selecting the 'Cal history inquiry' in the upper right corner of FIG. 3 to perform the recalibration The correction volume record can be inquired.

The inquiry output step (S105) may output the history information of the correction data according to a predetermined format. In FIG. 3, the 'Cal history inquiry' 302 enables inquiry according to the period set by the user and enables output in various formats. For example, it may be possible to output the contents of the 'Cal history inquiry' 302 in a report format or in a settlement form.

FIG. 4 illustrates a display screen on which a corrective action report output in the report format disclosed herein is output.

Referring to FIG. 4, if the 'correction action report' 401 is selected after setting the report output period at the upper right of FIG. 4, the contents of the internal condition management correction action for the corresponding period are outputted in the format of the report. These reports include history-controlled content, such as date, medical device name, medical test item, control substance name, target value, measurement value, W-GR content, And is output through the printer as a report approval form.

The above-described method for managing the quality of the medical examination data may be constituted by a computer-readable recording medium.

A computer-readable recording medium includes all kinds of recording media in which data that can be read by a computer system is stored. Examples of the computer-readable recording medium include a RAM, a ROM, a CD-ROM, a magnetic tape, an optical data storage device, a floppy disk, and the like.

In addition, the computer-readable recording medium may be distributed over network-connected computer systems so that computer readable codes can be stored and executed in a distributed manner. And, functional programs, codes, and code segments for implementing the recording method can be easily deduced by programmers in the technical field to which the present invention belongs.

In addition, the above-described method for managing the quality of medical examination data can be implemented by a quality management apparatus for medical examination data. That is, a method for managing the quality of the medical examination data or a method for managing the quality of the medical examination data may be constituted by a computer-readable recording medium and implemented in hardware.

5 is a diagram for explaining an embodiment of a history management device for statistical internal quality management of medical examination data disclosed in this specification.

5, the history management device for managing the statistical internal quality of medical examination data includes an input unit 501, a control unit 502, a display unit 504, and a storage unit 505, and the control unit 502 And an interface providing unit 503. The input unit 501 is implemented with the data input step described with reference to FIG. 1, and can be input by an input device, a network, or data transmission that the user can input. The control unit 502 is implemented as a data analysis step, and is capable of performing logical and mathematical operations by the central processing unit. The display unit 504 displays data analysis results or data output at the inquiry output step, and displays data analysis results including the quality management data so that the user can recognize them. The storage unit 505 stores data analysis results including the quality management data. The storage unit 505 can be implemented as a database, and is a device capable of reading and writing data. The interface providing unit 504 provides a means for outputting data to an output device such as a display and at the same time for inducing a user's input. The interface providing unit 504 may be implemented integrally with the control unit 502 or may be implemented by a separate means.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention is not limited to the disclosed exemplary embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. It can be understood that the modification and application of the present invention are possible. For example, each component specifically shown in the embodiments can be modified and implemented. It is to be understood that the present invention may be embodied in many other specific forms without departing from the spirit or essential characteristics thereof.

501: Input unit
502:
503 Interface Offering
504:
505:

Claims (7)

A data input step of receiving internal quality control data by an input unit;
A data analyzing step of discriminating between data within a predetermined evaluation criterion and data exceeding the predetermined criterion according to data input so as to input data or information on the internal quality control data exceeding the evaluation criterion data;
An interface providing step of outputting the data analysis result to a display unit and providing an interface providing unit for receiving a specific matter or action item data according to a result of the data analysis from a user;
A data storage step of storing the internal quality management data, the data analysis result, and the measure data in a database; And
Wherein the control unit includes an inquiry output step of outputting at least one of the internal quality management data, the data analysis result, and the measure data to the display according to a request of the user, A history management method for.
delete delete delete delete The method according to claim 1,
The interface providing step
A statistical internal quality control of the medical examination data, which provides an interface for inputting calibration data for the medical examination item and stores the personalization data of the user for inputting the correction data in the correction data, A history management method for.
delete

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